Autologous fat-derived stem cell treatment for early Alzheimer's disease.

Mesenchymal Stem Cell Therapy for Early Alzheimer's Disease

This trial will test whether infusions of a person's own fat-derived stem cells can reduce brain inflammation and improve thinking in adults with early Alzheimer's disease or mild cognitive impairment.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 60 Years to 80 Years
• Sex: All
• Sponsor: The University of Texas Health Science Center, Houston (Academic / other)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT06775964 on ClinicalTrials.gov

What this trial studies

This open-label Phase 1b/2a trial will treat 12 adults with late pre-symptomatic or prodromal Alzheimer's disease with four IV infusions of autologous, adipose-derived mesenchymal stem cells over a 13-week period. Stem cells are harvested from a small fat biopsy, processed, and returned to participants by vein to target neuroinflammation. Participants must have evidence of brain amyloidosis and an elevated peripheral inflammatory profile and will undergo MRI, cognitive testing, blood biomarker assays, and regular clinic visits for about one year. The primary aims are to characterize safety and tolerability and to see if the treatment lowers neuroinflammation, changes brain activity, or slows progression toward Alzheimer's disease.

Who should consider this trial

Good fit: Ideal candidates are English-speaking adults aged 60–80 with late pre-symptomatic or prodromal (MCI) Alzheimer's disease, MMSE ≥22, confirmed brain amyloidosis, and elevated blood inflammatory markers who can undergo a fat biopsy and frequent visits.

Not a fit: People without evidence of amyloid pathology or an inflammatory blood profile, those with more advanced dementia (MMSE <22), significant medical contraindications, or who cannot travel to Houston are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the treatment could reduce neuroinflammation, support brain function, and slow clinical progression in people with early Alzheimer's stages.

How similar studies have performed: Preclinical studies and small early-phase human work suggest MSCs can have anti-inflammatory and neuroprotective effects, but strong clinical evidence of efficacy in Alzheimer's disease remains limited.

Eligibility criteria

Inclusion Criteria:

1. Has signed an informed consent form before any assessment is performed as part of the study.
2. Be male or female between 60 and 80 years old.
3. Subject has been or is in process of being clinically diagnosed with late pre-symptomatic or mild cognitive impairment (MCI) due to AD (prodromal AD).
4. Mini-Mental State Examination (MMSE) score of ≥ 22
5. Has an MRI to evaluate AD pathology (may use previous if within 6mo.)
6. Has APOE status to evaluate AD pathology (may use previous result)
7. Proficiency in English is required because cognitive tests are administered in English only.
8. Has evidence of brain amyloidosis via PET Scan or Aβ42/40 ratios in CSF.
9. Has evidence of peripheral inflammatory profile based on CRP (≥ 8 mg/L), IL-6 (≥ 3.1 pg/mL), TNF-α (10 pg/mL), or erythrocyte sedimentation rate (ESR) (≥20 mm/h) in blood assays.
10. Is in the opinion of the Investigator, in good general medical health based upon medical history, physical examination, laboratory tests, vital signs and EKG.

Exclusion Criteria:

1. Current medical or neurological condition that might impact cognition or performance on cognitive assessments. (e.g., traumatic brain injury (TBI), Parkinson's disease (PD), multiple sclerosis, etc.)
2. Inability or unwillingness of patient to undergo neuropsychological testing.
3. Advanced, severe, progressive or unstable disease that may interfere with the safety, tolerability and study assessments, or put the subject at special risk. (e.g., significant cardiac disease, severe renal impairment, severe hepatic impairment, autoimmune disease, etc.)
4. History of malignancy of any organ system within the past 60 months, that in the opinion of the investigator would impede evaluation or interpretation of subject safety or study results.
5. Females of childbearing potential must not be pregnant.
6. Inability or unwillingness to undergo PET Scans.
7. Inability or unwillingness to undergo MRI Scans.
8. Positive blood test for either HIV, Hepatitis B, Hepatitis C or Syphilis
9. Positive for TSPO SNP rs6971
10. Inability or unwillingness to undergo Lumbar Punctures.
11. Inability or unwillingness to undergo infusions.
12. Any condition, which in the opinion of the investigator, would put the subject at undue risk or would interfere with evaluation of the investigational product or interpretation of subject safety or study results.

Where this trial is running

Houston, Texas

• The University of Texas Health Science Center at Houston (UTHealth) — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Paul E Schulz, MD — The University of Texas Health Science Center, Houston
• Study coordinator: Harshali Patel

Conditions Cognitive Dysfunction; Mild Cognitive Impairment; Cognitive Decline; Alzheimer's disease